The FDA has indicated its agreement with Bionovo's Chemistry, Manufacturing and Controls (CMC) plan for menopausal hot-flash treatment Menerba. The oral candidate, an estrogen receptor beta (ER-b) selective drug, is produced using botanical sources. Botanical drugs are complex mixtures that lack of a distinct active ingredient, according to the FDA.
The CMC plan involves revised analytical approaches to the drug's characterization and consistency as well as a process change from the Phase II material, according to an announcement. The FDA has asked to see selected batch records for review. The changes will be tried for 28 days in a bioequivalence study in rats as a precursor to Phase III testing.
Bionovo has already received Phase III guidance from the European Medicines Agency. It expects to initiate trials in the U.S. and Europe by year's end.
- here's the Bionovo announcement